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A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally Twice Per Week to Japanese Patients With Advanced Solid Tumors.


Phase 1
20 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

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Trial Information

A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally Twice Per Week to Japanese Patients With Advanced Solid Tumors.

Inclusion Criteria


Inclusion criteria

- Patients with histological or cytological confirmed advanced solid tumors, which
progressed despite standard therapy or for whom no standard therapy exists

- Life expectancy of at least 3 months

- No dysfunction of bone marrow

- No major impairment of renal and hepatic function

Exclusion criteria

- Gastrointestinal dysfunction, such as gastrectomy or malabsorption syndrome, that
could alter absorption of the study drug

- Receipt of any investigational compound within the 28 days prior to the first dose of
study drug, or failure to recover from the side effects of such prior therapy

- Receipt of other antineoplastic therapy including chemotherapy, hormone therapy,
immunotherapy, radiation therapy within the 28 days

- Patients known to be HIV, or hepatitis B or C viruses positive, or patients with the
presence of active or suspected acute or chronic uncontrolled infection

- Patients with a history of allergies to the camptothecin family of drugs

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability assessed by Adverse Events Characterization of the pharmacokinetic profile of gimatecan Anti-tumor activity assessed by Response Evaluation Criteria in Solid Tumors RECIST)

Principal Investigator

Novartis

Investigator Role:

Study Chair

Investigator Affiliation:

Novartis

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

CLBQ707A1103

NCT ID:

NCT00487058

Start Date:

May 2007

Completion Date:

Related Keywords:

  • Advanced Solid Tumors
  • Gimatecan
  • topoisomerase I inhibitor
  • advanced solid tumors
  • Neoplasms

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